The translation of experimental cell-based therapies to
volume produced commercially successful clinical
products that satisfy the regulator requires the
development of automated manufacturing processes to
achieve capable and scaleable processes that are both
economic and able to meet the unpredictable demands of
the market place. The Healthcare Engineering group at
Loughborough has conducted novel demonstrators of the
transfer of manual human cell culture processes to the
CompacT SelecT (The Automation Partnership)
automated cell culture platform, including an osteoblast
cell line, embryonic carcinoma cell line, primary bone
marrow-derived mesenchymal stem cells, primary
umbilical cord-derived progenitor cells, and human
embryonic stem cells. The work aims to develop and
optimize automated cell culture processes for
manufacturing cell-based therapies in a quality system and
current good manufacturing practice (cGMP) compliant
manner and is underpinned by the application of a sixsigma
inspired quality engineering approach.
In this technical brief, we outline the need for
automated cell culture systems and automated process
engineering for the manufacture of cell populations for
therapeutic applications. We review the transfer of
a manual cell culture process to an automated process and
the subsequent methodology for process improvement
using examples from our laboratory of the application of
these principles to an important regenerative medicine cell
type, the human mesenchymal stem cell. We believe that
systematic process improvement methodologies
combined with the process stability provided by
automation are essential to engineer optimized cGMP
compliant manufacturing processes that will be required to
realize the promise of cell-based therapies